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The FDA regulates cord blood bank operations with strict guidelines. However, additional licenses maybe required in some states. Laboratories should also be AABB accredited. The AABB promotes the highest standards of care for both patients and donors in all aspects of blood banking, transfusion medicine, relationship testing, hematopoietic, cord blood and other cellular therapies.
Cord blood can’t be used to treat everything. If your child is born with a genetic condition such as muscular dystrophy or spina bifida, then the stem cells would have that condition, says Dr. Kurtzberg. But if the cord blood donor is healthy and there is a sibling or another immediate family member who has a genetic condition, the cord blood could be a good match for them.
Although cord blood is currently considered discarded human material, it should only be collected for banking with an institutional review board–approved protocol and with signed informed consent from a parent.42,43 Pertinent donor information communicated to the cord blood bank should be kept confidential by the cord blood bank and used only to report important medical information obtained during the cord blood collection, processing, and screening process that is relevant to the safety of the donor and family. If cord blood was collected from a newborn who subsequently developed a genetic, immunologic, or malignant neoplastic disorder, parents should notify the cord blood bank so that the unit is not used for transplantation. All cord blood units banked for potential use should be tested for infectious diseases, similar to those tested in a blood bank, and for hereditary hematologic diseases. The informed consent must contain information pertaining to what tests are to be performed on the cord blood and how the parents will be informed if test results are abnormal. Pediatricians should be aware that legal cases relating to the duty of a physician to warn parents about the risks of inheriting a genetic disease are new and untested. Pediatricians should remain vigilant, because future cases may define who has a legal duty to notify parents about genetic abnormalities identified during cord blood testing. Informed consent should be obtained before the onset of active labor and before cord blood collection.
Lamaze International has created a continuing education home study based on this article. Visit the Lamaze Web site (www.lamaze.org) for detailed instructions regarding completion and submission of this home study module for Lamaze contact hours.
To save money, public banks will not even process a cord blood donation unless they know in advance that they are going to keep it. When the collection first arrives at the lab, it is passed through a cell counting machine. Only collections that have at least 900 million nucleated cells are kept. As a result, over 60%-80% of cord blood donations are discarded. The public bank must absorb the expense of the collection kit and delivery charges for discarded blood; typically $100 per unit.
Childbirth educators may be one of the first resources that an expectant family turns to in order to gain more knowledge to make an informed decision about collecting umbilical cord blood in the birthing process. Therefore, the childbirth educator should be well versed on the topic, so that as questions from class participants arise, the multiple facets of umbilical cord blood banking can be explored.
Let’s look back at the expectant couple in my childbirth class who asked about banking their infant’s umbilical cord blood. They should not base their decision to bank the umbilical cord blood on the type of anticoagulant used to preserve the sample; likewise, they should not obtain all of their information on cord blood banking from the private cord blood bank, whose major agenda is to gain another client. Instead, they must be encouraged to research various resources for reliable information (see Table 4). If they have evidence that stem cells are used currently to treat a specific disease process that is affecting a family member, and is not simply a proposed idea, then it might be in their best interest to privately bank the umbilical cord blood. However, they should be aware that simply banking the cord blood does not ensure a cure, and they would most likely be banking the blood not for the current baby, but for some other family member. They must also be aware of the cost involved in the banking process. Finally, if they do not have a relative with a disease process treated with stem cells or there is no evidence that stem cells are used to treat the diseases that are known to be in their family, then they should consider public banking of the umbilical cord blood (if they have access to a public cord blood bank).
Some ethical concerns over umbilical cord blood banking warrant mention. As previously stated, the AAP (2007) acknowledges that claims in advertisements for private cord blood banks are not accurate. In fact, some of the statements made by private cord blood banks are outright misleading (Fox et al., 2007), which raises questions about how informed consent for cord blood collection is obtained. Legally, the cord blood belongs to the child, but the consent of the mother alone is usually obtained for collection, and the consent of the father is rarely considered (Ballen, 2006). Because the cord blood now has a “value,” the person who obtains consent and that same person’s professional connection to the private cord blood bank may come into question (Pinch, 2001).
Researchers continue to investigate new applications of stem cells. Ballen (2006) reported on studies examining the use of stem cells for treating autoimmune diseases, such as lupus, systemic sclerosis, and multiple sclerosis. Gunning (2007) reported on stem cell research for regenerative uses for heart attacks, stroke, spinal cord injury, diabetes, liver injury, and even traumatic brain injury. However, Gunning also noted that these regenerative uses for stem cells are purely in the research stage and, so far, no tangible evidence supports any clinical uses beyond the diseases that are currently being treated.
After harvesting, the umbilical cord blood is taken to a cord blood bank where it will be tested to make sure that it is clear of disease and other contaminants. Before being frozen, a cryopreservant is added to the cord blood so that the stem cells are able to be frozen without damaging them, after which they are stored in a liquid nitrogen Cord Blood storage tank at –196 Celsius.
The main purpose of a cord blood company is to store umbilical cord blood for families in case they need to access it for future use. Cord blood from a baby is stored because it has the potential to help treat blood or immune system diseases. There are both private and public cord blood companies, sometimes referred to as cord blood banks.
Today, many conditions may be treatable with cord blood as part of a stem cell transplant, including various cancers and blood, immune, and metabolic disorders. Preserving these cells now may provide your family potential treatment options in the future.
One of the first things I learned is that the couples in my childbirth class were not unique. In fact, research indicates that most pregnant women are underinformed about the issue of cord blood banking (Fox et al., 2007). While reviewing the literature on cord blood banking, I also found that the information available for nurses and childbirth educators often comes from private cord blood banks or their employees (Cord Blood Registry, 2009; Wolf, 1998, 1999), thus introducing the chance of bias.
Targeted efforts should be made to recruit underserved minorities (black, Hispanic, American Indian/Alaska Native individuals) in public cord blood–banking programs to extend to them potential treatments afforded other segments of society.
Marketing materials by Viacord and Cord Blood Registry, the two largest companies, do not mention that cord blood stem cells cannot be used by the child for genetic diseases, although the fine print does state that cord blood may not be effective for all of the listed conditions.
Family Cord, located in Los Angeles, has a high-quality lab, a top rating from the Better Business Bureau, and accreditation from AABB; it’s also been in business since 1997. Family Cord is one of the few banks that will also cover the cost of cord blood banking for the first year (there’s an annual fee after the first year) in cases where a baby has a sick sibling or another family member who could benefit from the cord blood.
The cord blood collection process is simple, safe, and painless. The process usually takes no longer than five minutes. Cord blood collection does not interfere with delivery and is possible with both vaginal and cesarean deliveries.
Richardson SM, Hoyland JA, Mobasheri R, Csaki C, Shakibaei M, Mobasheri A. Mesenchymal Stem Cells in Regenerative Medicine: Opportunities and Challenges for Articular Cartilage and Intervertebral Disc Tissue Engineering. J Cell Physiol. 2010; 222(1):23-32.
For transplants, the primary advantage of cord blood stem cells over stem cells from adults is that they cause much less graft versus host disease (GvHD). In order to safely transplant adult stem cells, the patient and donor must match over at least 10 of 12 tissue types called Human Leukocyte Antigens (HLA), or 83% HLA match. By comparison, medical outcomes are just as good with cord blood that has a 4 out of 6 or 67% HLA match.
Rocha V, Wagner JE Jr, Sobocinski KA, et al. Graft-versus-host disease in children who have received a cord-blood or bone marrow transplant from an HLA-identical sibling. Eurocord and International Bone Marrow Transplant Registry Working Committee on Alternative Donor and Stem Cell Sources. N Engl J Med.2000;342 :1846– 1854
These are diseases for which transplants of blood-forming stem cells (Hematopoietic Stem Cell Transplants, HSCT) are a standard treatment. For some diseases they are the only therapy, and in other diseases they are only employed when front-line therapies have failed or the disease is very aggressive. The lists below include ALL therapies that use blood-forming stem cells, without distinction as to whether the stem cells were extracted from bone marrow, peripheral blood, or cord blood.
Private cord blood banking costs $2,000 to $3,000 for the initial fee, and around another $100 per year for storage. While that may seem like a hefty price tag, many expectant parents may see it as an investment in their child’s long-term health.
Cord blood transplants aren’t entirely new — they’ve been in use for about 20 years. In fact, the outcome of transplants has improved in the last 10 years, says Joanne Kurtzberg, M.D., director of the pediatric bone marrow and stem cell transplant program at Duke University.
Ozkaynak MF, Sandoval C, Levendoglu-Tugal O, Jayabose S. A pilot trial of tandem autologous peripheral blood progenitor cell transplantation following high-dose thiotepa and carboplatin in children with poor-risk central nervous system tumors. Pediatr Hematol Oncol.2004;21 :635– 645
Cord blood has been shown to contain pluripotent stem cells that have the potential to differentiate into nonhematopoietic tissue, such as cardiac, neurologic, pancreatic, and skin tissue, in vitro.53,54 Extensive laboratory research is taking place to explore the potential therapeutic benefit of cord blood under these circumstances. The results of this research will be necessary to formulate future recommendations regarding autologous cord blood banking.
After a baby is born, the umbilical cord and placenta are no longer needed and are usually discarded. However, the blood remaining in the umbilical cord and placenta is rich with blood-forming cells. (These cells are not embryonic stem cells.) By collecting and freezing this blood, the healthy blood-forming cells can be stored and may later be used by a patient who needs them.
CBR works with Quick International, a private courier service with 30 years of experience as the market leader in the transport of cord blood, tissue, organs, and the U.S. blood inventory. CBR offers our clients a unique “Track My Kit” system to provide progress updates as the kit containing the cord blood travels to our lab. If it gets lost or damaged while in transit with Quick International, you are covered by a $2,500 warranty.
Cord tissue use is still in early research stages, and there is no guarantee that treatments using cord tissue will be available in the future. Cord tissue is stored whole. Additional processing prior to use will be required to extract and prepare any of the multiple cell types from cryopreserved cord tissue. Cbr Systems, Inc.’s activities for New York State residents are limited to collection of umbilical cord tissue and long-term storage of umbilical cord–derived stem cells. Cbr Systems, Inc.’s possession of a New York State license for such collection and long-term storage does not indicate approval or endorsement of possible future uses or future suitability of these cells.
In 1988, a 5-year-old named Matthew with a rare type of anemia received umbilical cord blood cells from his newborn sister, who didn’t have the disease. That transfer, called an umbilical cord blood transplant, worked, and the boy was soon free of the disease.
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Anak S, Saribeyoglu ET, Bilgen H, et al. Allogeneic versus autologous versus peripheral stem cell transplantation in CR1 pediatric AML patients: a single center experience. Pediatr Blood Cancer.2005;44 :654– 659
There are several advantages of using umbilical cord blood stem cells over bone marrow stem cells for transplants (see Table 2). The first advantage is that umbilical cord blood is relatively easy to collect and process. Once considered a substance to be thrown away after a birth, now the cord blood can be easily saved. After it is saved and sent to a storage facility, the cord blood is quickly available for use within days to weeks after processing. In contrast, bone marrow stem cells can take much longer to find a match, collect the sample, and process. The process for bone marrow transplantation can take from weeks to months. The collection process for cord blood is not painful to either mother or child and can be done either prior to or after the delivery of the placenta (Gonzalez-Ryan, VanSyckle, Coyne, & Glover, 2000; Percer, 2009). Bone marrow transplants, on the other hand, require the donor to be hospitalized, anesthetized, and experience postcollection pain and discomfort. Thus, compared to cord blood, bone marrow collection and transplantation of stem cells are more costly (Drew, 2005; Moise, 2005).
Basing your decision solely on the price of service may actually cost you in the long run. This is why we look at the quality of cord blood services provided and the costs of maintaining state of the art facilities.
Smith F, Kurtzberg J, Karson E, et al. Umbilical cord blood collection, storage and transplantation: issues and recommendations for expectant parents and patients. Cancer Res Ther Control.1999;10 :217– 226